ASTM Level 2 Surgical Face Mask

Basic Information

• Brand Name: ASTM Level 2 Surgical Face Mask
• Primary DI: 00850019294002
• Version / Model: 20-1003-SFM2
• Company Name: Premier Guard Usa, LLC
• Labeler DUNS: 117537165
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2021-11-24
• Public Version: 3
• Public Version Date: 2022-06-27
• Public Version Status: Update
• Public Device Record Key: a6185ede-142c-419f-9fda-f5034a17f729

Device Description

3-ply, single-use disposable surgical mask with an ASTM Level 2 rating. Made with elastic ear loops that do not contain natural rubber latex. Carton 50 pcs

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FXX	Mask, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66199	Surgical/medical face mask, non-antimicrobial, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850019294002	GS1
Unit of Use	00850019294347	GS1
Package	20850019294006	GS1	Case	40	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K202595	000